To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 40 mg - Tabular View

Tracking Information

First Received Date ^ICMJE

January 11, 2006

Last Updated Date

October 23, 2009

Start Date ^ICMJE

February 2006

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Percent Change From Baseline to Week 6 in Low-Density Lipoprotein (LDL)-C [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Change in LDL-C

Change History

Complete list of historical versions of study NCT00276484 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Percent Change From Baseline to Week 6 in High-Density Lipoprotein Cholesterol (HDL-C) [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
Percent Change From Baseline to Week 6 in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) [ Time Frame: Baseline and 6 Weeks ] [ Designated as safety issue: No ]
Percent Change From Baseline to Week 6 in Total-Cholesterol [ Time Frame: Baseline and 6 Weeks ] [ Designated as safety issue: No ]
Percent Change From Baseline to Week 6 in Triglycerides (TG) [ Time Frame: Baseline and 6 Weeks ] [ Designated as safety issue: No ]
Percent Change From Baseline to Week 6 in Apolipoprotein B (Apo B) [ Time Frame: Baseline and 6 Weeks ] [ Designated as safety issue: No ]
Percent Change From Baseline to Week 6 in Apolipoprotein A-I (Apo A-I) [ Time Frame: Baseline and 6 Weeks ] [ Designated as safety issue: No ]
Percent Change From Baseline to Week 6 in Total-Cholesterol (TC):High-Density Lipoprotein Cholesterol (HDL-C) Ratio [ Time Frame: Baseline and 6 Weeks ] [ Designated as safety issue: No ]
Percent Change From Baseline to Week 6 in Low-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (LDL-C:HDL-C) Ratio [ Time Frame: Baseline and 6 Weeks ] [ Designated as safety issue: No ]
Percent Change From Baseline to Week 6 in Apolipoprotein B:Apolipoprotein A-I (Apo B:Apo A-I) Ratio [ Time Frame: Baseline and 6 Weeks ] [ Designated as safety issue: No ]
Percent Change From Baseline to Week 6 in Non-High-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (Non-HDL-C:HDL-C) Ratio [ Time Frame: Baseline and 6 Weeks ] [ Designated as safety issue: No ]
Percent Change From Baseline to Week 6 in C Reactive Protein (CRP) [ Time Frame: Baseline and 6 Weeks ] [ Designated as safety issue: No ]
Number of Patients Who Attained Target Low-Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6 [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Change in other lipid variables

Descriptive Information

Brief Title ^ICMJE

To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 40 mg

Official Title ^ICMJE

A Multicenter, Rand., Double-Blind, Titration Study to Evaluate & Compare the Efficacy & Safety of Ezetimibe Plus Atorvastatin Vs Atorvastatin in Hypercholesterolemic Pts. at High Risk for CHD Not Adequately Controlled on Atorvastatin 40 Mg

Brief Summary

To Evaluate and Compare the Efficacy and Safety of Ezetimibe Plus Atorvastatin Versus Atorvastatin in Hypercholesterolemic Patients at High Risk for Coronary Heart Disease Not Adequately Controlled on Atorvastatin 40 mg.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Hypercholesterolemia

Intervention ^ICMJE

Drug: atorvastatin
Drug: ezetimibe

Study Arms / Comparison Groups

Active Comparator: Atorvastatin 80 mg
Experimental: Atorvastatin 40 mg + ezetimibe 10 mg

Publications *

Leiter LA, Bays H, Conard S, Bird S, Rubino J, Hanson ME, Tomassini JE, Tershakovec AM. Efficacy and safety of ezetimibe added on to atorvastatin (40 mg) compared with uptitration of atorvastatin (to 80 mg) in hypercholesterolemic patients at high risk of coronary heart disease. Am J Cardiol. 2008 Dec 1;102(11):1495-501. Epub 2008 Oct 23.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

579

Completion Date

March 2008

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patient with LDL-C >70 mg/dL & on a stable dose of atorvastatin 40 mg

Exclusion Criteria:

Pregnant or lactating women or intending to become pregnant
Patient with sensitivity or intolerance to ezetimibe or atorvastatin

Gender

Both

Ages

18 Years to 79 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00276484

Responsible Party

Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.

Study ID Numbers ^ICMJE

2005_105, MK0653-090

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP